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Manager, GQC Support

ManagerManagerFull TimeRemoteSeniorTeam 1,001-5,000Since 2003H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

1 day ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Manager, GQC Support

UBC

• Oversee and manage the controlled documents lifecycle and corresponding test assessments. • Ensure compliance with internal policies and procedures and target review cycle frequency including appropriate formatting of SOP documents. • Support SOP review and approval process as deemed appropriate • Oversee and manage training related activities (e.g. SOP table of content, training matrix, training decks, other training documentation) • Oversee and provide assistance with CAPA administrative activities (data entry, effectiveness checks, process improvement, ensure process is managed in compliance with policies and procedures, etc.) • Support and assist with GQC IT systems maintenance and change control (CAPA, electronic Document and Learning Management System, other) • Oversee and manage the Regulatory/Client Audit Support functions • Audit scheduling and audit calendar maintenance • Meeting coordination/logistics • CDA Requests • Auditor Code of Conduct • Setting up internal trackers and portals • Setting up and providing secure Box access for auditor(s) when required • Quality Compliance documentation review prior to and during audit. • Ensure audit reports and responses are stored as per UBC record retention procedures. • Provide administrative support (i.e., agenda, minutes, metrics) for the Global Quality Compliance department. • Assist in department-related special projects. • Other duties as assigned.

Job Requirements

  • Bachelor’s degree required preferably in Life Sciences, Clinical, or Business area of study with 5 years quality assurance/compliance/auditing experience within a GCP environment.
  • Previous experience of working at a CRO
  • Experience hosting regulatory inspections and supporting client audits
  • Must have a minimum of 5 years GCP experience.
  • Extensive knowledge of applicable pharmaceutical/biotechnology regulatory requirements (e.g., ICH, GCP, GxP, FDA/CFR, EMA, MHRA, EU GVP)
  • Preferably at least 1 year of previous managerial/supervisory experience (i.e., experience managing teams and/or staff).
  • Proficient PC knowledge required including Microsoft Office Suite (i.e., Word, Excel, Powerpoint, Outlook), Internet, SharePoint.
  • Experience in management of the corrective and preventive action (CAPA) lifecycle
  • Experience in Quality Management Systems maintenance
  • Experience in management of standard operating procedures (SOPs)/policies
  • Experience in implementation and management of process improvement
  • Excellent verbal presentation and written communications skills.
  • Proven interpersonal and relationship building skills.
  • Proven skills in planning, analysis, and creative problem solving.
  • Strong organizational and time management skills.

Benefits

  • Competitive salaries
  • Growth opportunities for promotion
  • 401K with company match*
  • Tuition reimbursement
  • Flexible work environment
  • Discretionary PTO (Paid Time Off)
  • Paid Holidays
  • Employee assistance programs
  • Medical, Dental, and vision coverage
  • HSA/FSA
  • Telemedicine (Virtual doctor appointments)
  • Wellness program
  • Adoption assistance
  • Short term disability
  • Long term disability
  • Life insurance
  • Discount programs

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